Sample container cap with centrifugation status indicator device

ABSTRACT

A sample container cap is disclosed. The sample cap container includes a sample cap body capable of covering an opening of a sample container and a centrifugation status indicator device in the top of the sample cap body. The centrifugation status indicator device includes: a first substance having a first density and a first color, and a second substance having a second density and a second color. The centrifugation status indicator device displays the first substance when the sample container has been centrifuged. The first substance can be a gel, and the second substance can include a plurality of particles. The second density is higher than the first density and the second color is different from the first color.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.13/671,454, filed on Nov. 7, 2012, and entitled “Specimen ContainerDetection,” which claims priority to U.S. Provisional Patent ApplicationNo. 61/556,667, filed Nov. 7, 2011 and entitled “Analytical System andMethod for Processing Samples.” U.S. patent application Ser. No.13/671,454 also claims priority to U.S. Provisional Patent ApplicationNo. 61/616,994, filed Mar. 28, 2012 and entitled “Analytical System andMethod for Processing Samples.” U.S. patent application Ser. No.13/671,454 also claims priority to U.S. Provisional Patent ApplicationNo. 61/680,066, filed Aug. 6, 2012 and entitled “Analytical System andMethod for Processing Samples.” All of these applications are hereinincorporated by reference in their entirety for all purposes.

BACKGROUND

Conventional medical laboratory systems contain many segments forprocessing patient samples, some of which are automated and some ofwhich require manual operation. Laboratory systems today have becomemore efficient due to those segments which have become automated.However, there are still several components of medical laboratorysystems that can be automated in order to reduce the time it takes foran analysis of a sample, reduce the need for manual operation of thesystem, and reduce the space required by machinery.

Generally, the laboratory process can be organized into four phases:association, pre-analytical, analytical, and post-analytical. These fourphases typically occur within any laboratory process. However, someconventional labs may have a process that uses standalone unitsthroughout the lab while others may connect some of the units with aconveyance system to move the sample from unit to unit. These two styleshave some common and some different processing needs. Additionally, someconventional labs may consistently process the same types of sampletubes (e.g., as in those from a kit) while others may have a wide rangeof tube types they must accommodate. Furthermore, many labs may have apreference for a particular manufacturer of an analyzer while others mayuse all of the analyzers from one manufacturer.

Thus, there is a need for a more efficient system and method forprocessing patient samples that can accommodate both a process usingstandalone units and units connected with a conveyance system, a varietyof sample tube types, and analyzers from any manufacturer.

One aspect of automated laboratory systems relates to tubeidentification. Automatic tube identification is needed in a laboratorysystem so that the laboratory system knows how to process samples in thesample tubes.

Conventional tube-in-rack detection typically utilizes image analysistools on 2-dimensional images acquired by one camera or a plurality ofcameras in order to determine objects in the field of view of thecameras. This technology is well known in various fields, including,e.g., the analysis of pathology samples by microscopes.

In other fields, this technology may be used to identify objects inmoveable loading or unloading means of a system, including, e.g.,identifying drawers of a workbench. See, e.g., WO/2010/017528. A seriesof images can be taken by each camera during the opening and closing ofthe drawer and stitched together to generate an overview image. Withinthis overview image, single objects can be detected by image analysis.

In the field of laboratory automation systems, it is well known thatsingle objects, such as a cap or closure of a sample tube, located in aholding rack can be identified by employing image analysis algorithms ontop views of the hold racks. However, the image analysis algorithms aretypically limited to the identification of only the single object and donot identify other details of the objects within the image.

Other tube identification mechanisms include the use of sample tubemarkers. Conventional sample tube markers used to identify a sample tuberequiring immediate analysis typically include self-adhering labels(e.g., colored labels indicating urgency), “urgent” stickers, or simplya handwritten note indicating urgency on already existing labels. Theseurgent sample tube markers are inefficient and non-automated, requiringa laboratory technician to apply and/or handwrite the indication ofurgency.

Additionally, conventional sample tube markers used to identify acentrifuged sample may include g-force sensitive labels. These labelsmeasure whether there was an impermissibly high shock during transport.However, such labels are on the side of sample tubes, and as such cannotbe easily reviewed or identified by overhead cameras and the like.

Embodiments of the invention address these and other problems,individually and collectively.

BRIEF SUMMARY

Embodiments of the technology relate to systems and methods forefficiently processing patient samples.

One embodiment of the invention is directed to a system. The systemincludes at least one image acquisition device configured to obtain oneor more images of a sample container holder or a sample container in thesample container holder when positioned above the sample containerholder or the sample container in the sample container holder. Thesystem also comprises an image analysis device coupled to the at leastone image acquisition device and configured to analyze, by a processor,the one or more images of the sample container holder or samplecontainers in the sample container holder, to determine (a) a presence,absence, or characteristic of the sample container holder, wherein thecharacteristic of the sample container holder comprises a color or shapeof the sample container holder, or a label or marker associated with thesample container holder, or (b) a presence, absence or characteristic ofthe sample container in the sample container holder, wherein the samplecontainer characteristic includes one or more of a color or shape of thesample container, or a label or marker associated with the samplecontainer.

Another embodiment of the invention is directed to a method. The methodcomprises acquiring, by the at least one image acquisition device, atleast one image of the sample container holder with the samplecontainers comprising samples, and analyzing, by an image analysisdevice, the at least one image. The at least one image is analyzed todetermine (a) a presence, absence, or a characteristic of the samplecontainer holder, wherein the characteristic of sample container holdercomprises a color or shape of the sample container holder, or a label ormarker associated with the sample container holder, or (b) a presence,absence or a characteristic of the sample container in the samplecontainer holder, wherein the sample container characteristic includesone or more of a color or shape of the sample container holder, or alabel or marker associated with the sample container.

Another embodiment of the invention is directed to a sample containercap comprising a cap body capable of covering a sample container body,and a movable element coupled to the cap body. The movable element iscapable of indicating a status of the sample container for processing ina laboratory automation system.

Another embodiment of the invention is directed to a sample containercap comprising a sample cap body capable of covering an opening of thesample container. A centrifugation status indicator device is in thesample cap body.

These and other embodiments of the technology are described in furtherdetail below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a block diagram of components associated with phases of alaboratory automation system.

FIG. 2 shows a block diagram of components associated with apre-analytical phase of a laboratory automation system.

FIG. 3 shows a system diagram according to an embodiment of theinvention.

FIG. 4 shows a high-level block diagram of a tube and rackidentification system showing elements of an analysis device accordingto an embodiment of the invention.

FIGS. 5(a)-5(c) show examples of camera units for sample tube or rackdetection and analysis.

FIG. 6 show an example of an original image and a resulting analyzedimage of a rack with sample tubes after a presence detection analysis.

FIG. 7 shows a sample tube with a sample tube body and a sample tubecap.

FIGS. 8(a)-8(b) depict one example of a top perspective view of a caphaving an urgent sample indicator.

FIGS. 9(a)-9(b) depict exemplary color indicators of centrifugationindicators.

FIGS. 10(a)-10(b) show a non-centrifuged cap embodiment from a sidecross-sectional view and a top plan view, respectively.

FIGS. 11(a)-11(b) show a centrifuged cap embodiment from a sidecross-sectional view and a top plan view, respectively.

FIG. 12 show a block diagram of an exemplary computer apparatus.

DETAILED DESCRIPTION

Embodiments of the invention relate to different ways to identify samplecontainers in an automated laboratory analysis system. One embodiment ofthe invention is directed to a system. The system includes at least oneimage acquisition device configured to obtain one or more images of asample container holder or a sample container in the sample containerholder when positioned above the sample container holder or the samplecontainer in the sample container holder. The system also comprises animage analysis device coupled to the at least one image acquisitiondevice and configured to analyze, by a processor, the one or more imagesof the sample container holder or sample containers in the samplecontainer holder, to determine (a) a presence, absence, orcharacteristic of the sample container holder, wherein thecharacteristic of the sample container holder comprises a color or shapeof the sample container holder, or a label or marker associated with thesample container holder, or (b) a presence, absence or characteristic ofthe sample container in the sample container holder, wherein the samplecontainer characteristic includes one or more of a color or shape of thesample container, or labels and markers associated with the samplecontainer.

In embodiments of the invention, a “sample container” may have anysuitable shape or form. In some embodiments, the sample container may bein the form of a sample tube, which may have an aspect ratio of greaterthan about 3:1. Such sample containers may be made or any suitablematerial including plastic, glass, etc. They may further include asample tube body with a closed end and an open end, as well as a capthat is structured to cover and attach to the open end of the sampletube body.

In embodiments of the invention, a “sample container holder” may be inany suitable shape or form, and may comprise any suitable material. Insome cases, the sample tube holder may be in the form of a sample tuberack. Sample container holders may include an array of recesses that canreceive sample containers (e.g., sample tubes). They may also compriseany suitable material including plastic.

As discussed above, many conventional laboratory systems may have aprocess that uses standalone units throughout the lab, requiring thatthe samples be manually transported between each standalone unit, whileothers may connect some of the units with a conveyance system to movethe samples from unit to unit. Additionally, as discussed above, sampletube sizes and equipment from different manufacturers may be constraintsin conventional laboratory systems. Such conventional technology is slowand inaccurate. Embodiments of the present technology can be used in amodular laboratory system which is capable of accommodating differentlaboratory units and transport systems, sample tube sizes, andmanufacturers by using more universal components and by groupingfunctions required by most laboratory systems into five basic functionalunits: (1) manager, (2) centrifuge, (3), aliquotter, (4) output/sorter,and (5) storage units. These five basic functional units will bedescribed in more detail below.

In embodiments of the invention, the laboratory system operates acontrolled process using a central controller or scheduler. By keepingthe samples under the control of an intelligent scheduler, the systemprovides efficient usage of every instrument. The system can maintain aconsistent minimal turnaround time and maximizes the throughput of theentire system by maintaining control of the process and only deliveringsamples to instruments when those instruments are ready and available.

The laboratory system according to an embodiment of the inventionfurther utilizes one or more robotic gripper units mounted on roboticarms. Each robotic arm unit has a robotic gripper for gripping sampletubes and may be equipped with one or more means for detectinginformation about sample tubes. The terms “gripper” and “roboticgripper” are used interchangeably herein.

Use of a plurality of robotic gripper units in the laboratory systemalso increases sample processing efficiency. For example, a firstgripper, such as an input module gripper, identifies a sample tube andmakes data measurements as described above. After the first gripperdelivers the sample tube to a distribution area, a second gripper, suchas a distribution area gripper, delivers a sample tube to a subsequentmodule such as a centrifuge module or conveyor. The use of multiplegrippers allows an increase in processing efficiency over prior artsystems that use only a single gripper to receive, identify, and loadall samples on a conveyor track.

I. Overall System

A. Phases of Laboratory System

FIG. 1 depicts one embodiment of a medical laboratory system forprocessing patient samples. The laboratory system includes componentsassociated with the association phase 102, the pre-analytical phase 104,the analytical phase 106, and the post-analytical phase 108.

1. Association Phase

The association phase 102 is the first phase in the laboratory process.During this phase, the patient information, the requested tests for thepatient sample, and a unique laboratory identifier (e.g., a barcode) areassociated with one another. While the association phase 102 could beautomated, in some embodiments, the association phase is handledmanually. For example, in some embodiments, a laboratory technician(hereinafter referred to as a “user”) can assign a priority to thesamples. The samples are loaded into racks or directly onto the systemat specific entry points. Although grouping samples into a few basicpriority levels (e.g., urgent or high priority, medium priority, lowpriority, etc.) may be desirable to provide a more consistent turnaroundtime, it is not necessary. Processing patient samples can be based onany priority defined by the user. However, if a priority is notspecified, a priority can be assigned based on factors such asminimizing turnaround time, maximizing throughput, the availability ofprocesses, etc.

2. Pre-Analytical Phase

The pre-analytical phase 104 includes preparing patient samples foranalysis. During the pre-analytical phase 104, the patient and testinformation is deciphered, the process for analysis is planned, thequality checks are performed, the sample may be separated into itsconstituent components (e.g., centrifuged), the sample may be dividedfor parallel analytical processes, and/or the sample can be delivered toone or more analyzers and/or racks. The pre-analytical phase 104 managesthe flow of samples to different instruments and different analyzerswithin the lab system. This process management permits the system tooperate efficiently and with minimal instruments. Additionally, thepre-analytical phase 104 ensures that a backup of patient samples atdifferent points within the lab system does not occur along the process,or if a backup does occur, the pre-analytical phase 104 ensures that thebackup can be cleared quickly and without significant impact on theremainder of the system.

Embodiments of the system can identify the patient samples as quickly aspossible and determine the best scheduling of each sample to provide aconsistent minimal turnaround time and maximum throughput of theanalytical processes. The steps and organization of those steps in theprocess are designed to avoid backups of patient samples. Modules of thelab system can operate at a throughput speed that ensures processing ofsamples at the maximum throughput of the upstream processes. However, insome embodiments, at the aliquotter unit, the throughput may be managedby the introduction of samples upstream and by small queues at eachaliquotter station.

FIG. 2 is a more detailed depiction of the components associated withthe pre-analytical phase 104. The components associated with thepre-analytical phase 104 include seven modules: input module 202,distribution area 204, centrifuge module 206, decapper 208, serumindices measurement device 210, aliquotter 212, and output/sorter 214.Each of these modules may be physically and/or operationally coupled(directly or indirectly) to each other.

(a) Input Module

The input module 202 shown in FIG. 2 can accommodate a variety of tubes,racks, prioritizations, etc. and is capable of receiving a specimen.Racks of tubes and/or individual tubes can be loaded onto one of severallanes 216, which may be manually operated drawers and/or automateddevices. In FIG. 2, five lanes 216 are depicted. However, the lab systemcan have any number of lanes 216. The lanes 216 are assigned prioritiesin accordance with those assigned by the user. In some embodiments, thehighest priority lane (short turnaround time or “STAT”) may have a fixedposition for accepting a group of individual tubes from the user. Oncetubes are loaded in the STAT lane, they become the next tubes processed.Other lanes can be assigned different priority levels in any manner. Forexample, when the drawers are manually operated, assigning one priorityto at least two of the drawers and another priority to at least twoother drawers may allow the system to operate continuously on one drawerwhile the other drawer of the same priority is available to the user.

In some embodiments, while the input module 202 is processing a drawerof samples, the user may be informed that the drawer should not beopened by using an indication such as a light on the drawer or a lock onthe drawer. This may help maintain the process integrity and maximizethroughput. When processing is complete on the first drawer, the drawermay be identified to the user as available, and the system mayautomatically begin processing another drawer. Additionally, the samplescan be transferred to and from the drawers 216 of the input module 202using an input module gripper 228.

(b) Distribution Area Module

From the lanes (or drawers) 216 within the input module 202 of FIG. 2,one of at least two or more grippers 218 (discussed in more detailbelow) may select the highest priority tube and transport it to a fixedmatrix called the distribution area 204. The distribution area 204 iscapable of distributing a specimen to a desired component of thelaboratory automation system. During the transfer to this module by theinput module gripper 228, the levels of the sample's constituentcomponents are measured and photographs of the sample tube are taken.These photographs can be analyzed to determine the tube's manufacturer,diameter, height, cap color, etc. From this information, the volumes ofthe sample's components can be calculated, and an estimate of the totaltube weight can be made. This weight can be later used to aid inbalancing the centrifuge buckets in the centrifuge module 206, as willbe discussed in more detail below.

To protect the distribution area 204 from filling with low prioritytubes, a limit can be set on the number of tubes loaded into this areafrom the low priority input lanes. Moreover, the distribution area 204may have a reserved area to ensure STAT samples have continuous accessto the distribution area 204 from the STAT drawer in the input module202.

The distribution area 204 can be the holding area which permits thesystem to access test information associated with the sample tube in theassociation phase 102 and plan the analysis process for the sample. Thisenables the system to schedule a sample tube's process with respect tothe other sample tubes currently on the system. Scheduling enables theefficient processing of samples based upon priority without overloadingany step in the overall system, permitting the optimization ofturnaround time and throughput. Furthermore, the sample's schedule canbe updated throughout the process as the system's activity oravailability changes, providing real time active control of the sample.

Once the schedule is planned by the distribution area module 204, agripper 218 then selects the sample tube that is the next tube to betransferred to the next module based on the priority of the tubes withinthe distribution area 204. The selected sample tube is transported fromthe distribution area 204 to the conveyance system 220, to thecentrifuge module 206, or to an output drawer with an error area 222based on the analysis performed by the distribution area module 204.

If the sample tube is being moved to the centrifuge module 206, the tubecan be placed into the appropriate centrifuge adapter based upon theearlier weight estimation to ensure proper balance of the centrifugerotor. The centrifuge adapter is the component which carries the tubesupon a shuttle from the distribution area 204 to the centrifugewhereupon a robotic gripper transfers the centrifuge adapter with thetubes to a bucket of the centrifuge.

If the distribution area module 204 determines that the sample tube doesnot require centrifugation, the grippers 218 places the sample into acarrier on the conveyance system 220 with the barcode label properlyaligned to the carrier at the direction of the scheduler so as not tooverload downstream processes. More details on the conveyance system 220and the carriers will be discussed below. A carrier can refer to anysuitable device, which can be present in a conveyance system and cancarry or transport one or more sample containers or tubes. Exemplarycarriers may contain recesses which can hold the containers or tubes. Ifa problem exists with the sample (e.g., the volume is too low, thebarcode is unreadable, no test information is downloaded, etc.), thesample tube is moved to the error area 222 and the user is notified ofthe issue.

(c) Centrifuge Module

The sample tube may be moved from the distribution area 204 of FIG. 2 tothe centrifuge module 206 if the distribution area module 204 determinesthat the sample requires centrifugation before analysis of the sample.When a sample tube is to be transported from the distribution area 204to the centrifuge module 206, the sample tube is loaded by thedistribution area robot gripper 218 into a centrifuge adapter from thedistribution area 204. The adapters may locate and retain multiple tubesizes for centrifugation. The adapter sits in a shuttle 224 which movesbetween the distribution area 204 and the centrifuge module 206 once theadapter is filled with sample tubes. An adapter can be a device whichholds sample containers and can be used in a centrifuge. Such adaptersare commonly constructed of a polymeric material but not limited to andconstructed as a single piece having a shape which allows retention ofone or more containers in which a sample may be placed. In some cases,an adapter is inserted into a device mounted on or in a centrifugerotor. LabWare® (e.g., sample containers or tubes) holding the sample isinserted in the adapter.

When the sample tubes in the adapters arrive at the centrifuge module206 from the distribution area 204 via the shuttle 224, the adapters areloaded into an available centrifuge bucket. The configuration of theadapters allows for simplification of delivery to and removal from thecentrifugation buckets. Once loaded into a centrifuge bucket, thesamples can be centrifuged. The centrifuge module 206 may include one ormore centrifuges that are refrigerated to maintain the temperature ofthe sample. In FIG. 2, two centrifuges 206-1 and 206-2 are depicted. Thecentrifuges use a swinging centrifuge bucket rotor which produces levelsedimentation layers from which analyzers and pipettors can consistentlyaspirate the maximum volume of fluid. Once centrifugation is complete,the adapters can be removed from the centrifugation bucket and placed inan unloading area. The sample tubes are then removed from the adaptersin the unloading area and placed in carriers on the conveyance system220 for transport to the next module.

The timing for loading tubes into an adapter at the distribution module204, sending the tubes in the adapter to the centrifuge module 206 viathe shuttle 224, loading the adapter into a centrifuge bucket,centrifuging the samples, unloading the adapter from the centrifugebucket, and unloading the tubes from the adapter is such that theprocess can be continuous, allowing for the continual centrifugation ofsamples as they arrive at the centrifuge module 206 from thedistribution area 204. As the centrifuge completes a spin cycle, thelast tube in the distribution area 204 is loaded by the distributionarea gripper 218 into an adapter, and the shuttle 224 moves the adapterto a centrifuge in the centrifuge module 206. At the same time, anautomated door on the centrifuge opens and provides access to a bucketas the rotor indexes into position at the doorway. A centrifuge modulegripper 226 in the centrifuge module 206 removes the adapter that isalready in the bucket and moves that adapter to an area where the tubeswill be unloaded to carriers on the conveyance system 220. Next, thecentrifuge module gripper 226 selects an adapter that has been recentlyloaded with tubes from the distribution area 204 and deposits it intothe empty bucket. While the rotor indexes to the next bucket, apreviously emptied adapter is moved to the open position on the shuttle224 for loading with tubes from the distribution area 204 when theshuttle 224 returns to the distribution area 204.

After the final adapter is loaded into the centrifuge, the door closesand the spin cycle begins. The adapter shuttle 224 moves back to thedistribution area 204, and a centrifuge module gripper 226 begins tounload tubes from the adapters removed from the buckets into carriers onthe conveyance system 220. As the tubes are moved from the adapter tothe carrier, the heights of the sedimentation layers are measured andthe barcode on each tube is aligned with the carrier. If insufficientserum or plasma is present, the tube will be sent to an error arealocated in the output module 214.

If the scheduling algorithm predicts the overloading of an analyzer withsamples from the centrifuge module 206, the centrifuge module gripper226 can unload the samples and distribute the samples from the adaptersto the conveyance system. In some embodiments, the full cycle time ofthe centrifuges can be greater than or equal to, e.g., 360 seconds. Inorder to ensure optimal turnaround time (TAT) and throughput thecentrifuges are kept, e.g., 180 seconds out of phase for a 360 secondscentrifugation cycle. In some embodiments, downstream processes do notprevent the unloading of samples from the centrifuge adapters. If allthe remaining samples in an adapter are destined for unavailableprocess(es) and depending upon the unavailable process, sample tubes caneither be moved to a buffer in the centrifuge instrument or moved toanother buffer area elsewhere in the system.

The centrifuge module 206 may include an automated centrifuge controlledby a centrifuge controller. The automated centrifuge can be loaded withmultiple centrifuge buckets or receptacles, each bucket receivingmultiple sample tubes. The centrifuge includes a motor coupled to aspindle, a rotor assembly, a controller, a lid, and optionally, a liddrive. The centrifuge controller indexes or stops the spindle atselected positions for automated placement and removal of either tubes,adapters, or buckets. The lid has a closed position and an openposition, and the lid opens and closes in response to instructions fromthe centrifuge controller.

In some embodiments, before the loaded buckets are placed in thecentrifuge, the buckets can be balanced in a balance system. The balancesystem, which can be an included part of the centrifuge module 206,comprises a scale having sites for receiving and holding a plurality ofbuckets, and a balance controller for selectively depositing sampletubes in cavities of the buckets while correlating incremental weightchanges with the locations of each deposit for equalizing weight inpairs of the buckets. The balance controller can be implemented as abalance program within the central controller. The balance programmaintains a database of sample container weights. When a container'sweight is combined with the sample's weight, the balance program candetermine the optimum adapter cavity in which to place it therebymaintaining a balanced rotor within a tolerance. Sample weights are theproduct of density estimates and the sample volumes calculated fromliquid level measurements and container geometry obtained during theinitial pick-up from the input. In some embodiments, balance system mayalso include a supply of dummy loads in buckets for limiting weightvariations between buckets. The dummy loads may be weighted for limitingthe weight variations to not greater than, e.g., 10 grams betweenmembers of each pair of buckets.

In other embodiments, a scale need not be used. For example, in someembodiments, the weight of a sample container and a sample can beestimated, and the adapters can be automatically loaded to ensure abalanced rotor. In some cases, a picture of a sample tube may be taken,and the liquid level of a sample in the sample tube can be determined.Using information about the sample container (e.g., the sample containerweight) and the determined liquid level, the weight of the sample tubewith the sample in it can be estimated. In such embodiments, a scale isadvantageously not needed. Further dummy loads may also not be needed.

The centrifuge controller may operate to perform a number of functions,such as receiving and storing a centrifuge spin profile including arotor spindle speed and duration, indexing the rotor's sample stationsinto an access position, spinning the rotor in accordance with the cycleprofile, stopping the rotor with a predetermined sample station at theaccess position, etc.

(d) Decapper Module

The decapper module 208 of FIG. 2 is capable of decapping the cap fromthe sample tubes in carriers on the conveyance system 220 before theyare analyzed. The decapper system may clamp a sample tube and remove thecap from a sample tube. The decapper module 208 follows the distributionmodule 204 and the centrifuge module 206. For sample tubes which do notrequire cap removal (e.g., for instances in which the samples may onlyrequire sorting), the carrier on the conveyance system 220 will bypassthe decapper module 208. For sample tubes that require cap removal, thedecapper module 208 may remove the cap from the sample tube and depositthe cap in a biohazardous waste disposal container below the deck of thedecapper module 208. The biohazardous waste disposal container isremovable and replaceable to protect the user from biohazardous waste.

(e) Serum Indices Module

The serum indices module 210 of FIG. 2 is capable of measuring the serumindex of a sample. Typically, this function is performed during theanalytical phase 106. However, in some instances, certain laboratoriesmay prefer to address any quality issues prior to delivering the samplesto the analyzer. Thus, the serum indices module 210 provides thisquality control option for samples that should be tested during thepre-analytical phase 104. For samples that do not require a serum indexmeasurement, the sample may bypass the serum indices module 210.

The serum indices module 210 can be the next module after the decappermodule 208 since a serum indices measurement typically requires accessto the sample. Similar to the decapper module 208, the serum indicesmodule 210 may have a biohazardous waste disposal container below thedeck of this module. The container may be removable and replaceable toprotect the user from biohazardous waste.

(f) Aliquotter Module

The aliquotter module 212 of FIG. 2 divides the sample in a primary tubeinto multiple secondary tubes depending on how many tubes are needed foranalysis. This module may contain one or more pipettors for dividing thesample into secondary samples. Further details regarding the aliquottermodule 212 can be found in U.S. Provisional Patent Application Nos.61/556,667, filed Nov. 7, 2011, 61/616,994, filed Mar. 28, 2012, and61/680,066, filed Aug. 6, 2012.

3. Analytical Phase

Referring again to FIGS. 1 and 2, the analytical phase 106 includesperforming the actual measurements needed to process a sample andproduce results. This phase is typically composed predominantly of oneor more analysis instruments or analyzers. The analysis instruments oranalyzers can be any analysis instruments or analyzers known in the art.Typically, an analyzer may comprise a mechanism for selectivelyperforming one or more types of analyses on a specimen. The analyzer'scontroller is in communication with the central controller, so that thecentral controller can instruct the analyzer controller as to whatanalysis to perform for the specimen. Each analyzer's controller mayalso communicate analysis results to the memory of the centralcontroller.

For a laboratory system that has the components associated with thepre-analytical 104, analytical 106, and post-analytical 108 phasesconnected together via a conveyance system 220, the samples may movepast the output/sorter module 214 and onto analyzers. When the carrierreaches the destination analyzer for that particular sample, the carrierpulls off the main travel lane and forms a queue upstream of theanalyzer's access point to the conveyance system 220. The queue lengthis minimal because of the planning done by the scheduler while the tubewas still in the distribution area 204 and because of the controlledrelease of tubes by the distribution 204 and centrifuge 206 modules.

B. Tube or Rack Presence Detection Unit

The laboratory automated system may use a tube or rack presencedetection apparatus for detecting the presence of a sample tube or rackand its characteristics. Analysis tools or an image analysis device canbe used to analyze or process one or more images acquired by one or morecameras and determine objects in the field of view of the cameras. Theimage analysis device can determine the presence and characteristics ofeach rack and of each sample tube in the rack and identify each sampletube in the rack using the determined characteristics.

The embodiments of the invention that relate to the tube or rackidentification systems and methods can be used in any suitable part ofthe above-described system. For example, they may be used in theabove-described input module 202, output module 214, or any other partof the system that uses racks and tubes.

In embodiments of the invention, as noted above, an “image acquisitiondevice” may be used to capture images such as 2-D images of samplecontainers or sample container holders. Examples of image acquisitiondevices comprise cameras as well as detectors that can detect anysuitable type of electromagnetic energy.

In embodiments of the invention, “sample container characteristics” maycomprise any suitable characteristics about a sample container. Suchcharacteristics may relate to a physical characteristic of a containersuch as a tube body and/or tube cap. Examples of sample tubecharacteristics include cap color, cap shape, labels and markers.

In embodiments of the invention, “sample container holdercharacteristics” may comprise any suitable characteristics of a sampleholder. A sample container holder may include a number of recesses tohold an array of sample containers. Exemplary sample container holderscharacteristics may comprise any suitable characteristics including atleast one of a size, shape, or color, as well as labels and/or markersthat are associated with (e.g., on) the sample container holders.

1. Sample Tube or Rack Identification

FIG. 3 shows a high-level block diagram of some components in a sampletube and rack identification system according to an embodiment of theinvention. FIG. 3 shows a camera 1802 coupled to an image analysisdevice 1808. The image analysis device 1808 can also be coupled to agripper 228 and can provide instructions to it. The gripper 228 can thensecure a specific sample tube in a rack with sample tubes 1806(a).

Although the instructions provided by the image analysis device areprovided to a gripper 228 in this example, embodiments of the inventionare not limited thereto. For example, embodiments of the invention canprovide instructions to a central controller in the laboratoryautomation system to inform other downstream instruments or subsystemsthat a particular tube and/or rack has been identified. For example,once a particular sample tube in a sample rack has been identified, ascheduler in a central controller will know where that particular sampletube is in the system and can plan ahead for any subsequent processing.Thus, the instructions and/or analysis data provided by the imageanalysis device 1808 may be provided to any suitable downstreaminstrument or subsystem.

FIG. 4 shows a block diagram of an image analysis device 1808. It mayinclude a data input interface 1808(b) to receive data from the one ormore cameras (e.g. camera 1802), and a processor 1808(a) coupled to theinput interface 1808(b). The processor 1808(a) may also be coupled to adata output interface 1808(c) which provides data to suitable deviceswhich can manipulate and/or transport a sample tube. The centralprocessor 1808(a) may further be coupled to a memory 1808(d) which maycomprise shape determination module 1808(d)-1, a color determinationmodule 1808(d)-2, a marker and label determination module 1808(d)-3, atube presence detection module 1808(d)-4, and an instruction module1808(d)-5. The shape determination module 1808(d)-1 may comprisescomputer code, executable by the processor 1808(a), to determine theshape of a sample tube or rack. The color determination module 1808(d)-2may comprise computer code, executable by the processor 1808(a) todetermine a color of a sample tube cap or rack. The marker and labeldetermination module 1808(d)-3 may comprise computer code, executable bythe processor 1808(a) to determine marker or label associated with acap, tube body, or rack. The tube presence detection module 1808(d)-4may comprise code, executable by the processor, to determine the absenceor presence of a sample tube at a particular rack location within arack. The sample tube instruction module 1808(d)-5 may comprise code,executable by the processor 1808(a) to provide instructions to anexternal device via the data output interface 1808(c). The instructionsthat are provided may include instructions to a gripper unit, whichcause the gripper unit to locate and grip a particular sample tube ortubes in one or more racks. Note that any of the previously describedsoftware modules may function independently or together. For instance,the shape determination module 1808(d)-1 may operate with the colordetermination module 1808(d)-2 to identify both the shape of aparticular cap as well as its color, in order to identify the sampletube associated with the cap.

In methods according to embodiments of the invention, at least onecamera acquires at least one image of the rack with sample tubescomprising samples. The method further comprises analyzing, by the imageanalysis device, the at least one image to identify characteristics ofthe sample tubes and/or rack. If the sample tubes comprise differentsamples, then these samples may be in different sample tubes withdifferent characteristics, and the samples may be processed differently,after they have been identified. For example, after receivinginstructions from the analysis device, a first sample tube with a firstcharacteristic and a first sample could be sent to a storage unit by agripper (coupled to a robotic arm) that is capable of moving in threedirections (X, Y, and Z), while a second sample tube with a secondcharacteristic and a second sample may be sent to a centrifuge, prior tobeing analyzed.

The processor 1808(a) may comprise any suitable data processor forprocessing data. For example, the processor may comprise one or moremicroprocessors that function separately or together to cause variouscomponents of the system to operate.

The memory 1808(d) may comprise any suitable type of memory device, inany suitable combination. The memory 1808(d) may comprise one or morevolatile or non-volatile memory devices, which operate using anysuitable electrical, magnetic, and/or optical data storage technology.

FIG. 5(a) shows a system 1800 comprising a camera unit (e.g., 2-D arraysor line scanners) comprising a camera 1802 and illumination elements1804 (e.g., lights). The camera 1802 acquires a 2-D image for a targetobject can be used in the laboratory automation system to detect thepresence of and identify the target object. The camera 1802 and theillumination elements 1804 may be movable or stationary and may bemounted to a frame (not shown) in a processing module above racks withsample tubes. In this example, the target objects are multiple sampletubes 1806(a) being provided in a 6×6 rack 1806(b). The 2-D image canthen be further processed by image analysis software in the imageanalysis device and can detect the presence and to derivecharacteristics of the target object (e.g., sample tubes or racks), suchas tube cap indicators, rack markers, circular barcode labels, cap orrack color and shape, etc. The 2-D image can also be analyzed todetermine the presence or absence of a sample tube in various sampletube locations in the rack 1806. By analyzing the tube characteristicsand by analyzing the presence of the sample tubes in a rack, a gripperor other transport device knows which samples to select for furtherprocessing, and also knows whether or not additional samples can beplaced in the rack for further processing.

FIG. 5(b) depicts another embodiment of a system for sample tube or rackdetection and analysis. The image analysis device 1808 (e.g., cameraunit, 2-D arrays or line scanners) comprises a plurality of cameras1810(a), 1810(b), 1810(c) and illumination elements 1812 to acquire oneor more 2-D images of the target objects can be used in the laboratoryautomation system to detect the presence of and identify the targetobjects. The image analysis device 1808 comprising the plurality ofcameras 1810(a), 1810(b), 1810(c) is arranged on top of an input module202 facing the input area including the target objects. In this example,the target objects comprise sample tubes being provided in racks 1806provided on a plurality of parallel drawers 216 of the input module 202.As shown, the plurality of cameras 1810(a), 1810(b), 1810(c) can capturedifferent images 1820(a), 1820(b), 1820(c). Adjacent images 1820(a),1820(b) and 1820(b), 1820(c) can overlap so a larger image can bestitched together if desired.

The 2-D images obtained by the plurality of cameras 1810(a), 1810(b),1810(c) can then be further processed by image analysis software todetect the presence of and to derive characteristic features of thetarget objects (e.g., sample tubes and racks), such as tube capindicators, rack markers, circular barcode labels, cap or rack color andshape, etc. Either a series of images can be acquired by the imageanalysis device 1808 during the movement of the drawers 216, or anoverview image of the input area can be made in a closed state for thedrawers 216.

FIG. 5(c) depicts another embodiment of a camera unit for sample tube orrack detection and analysis. A camera unit 1814 (e.g., 2-D arrays orline scanners) having a camera 1816 and illumination elements 1818 toacquire 2-D images for target objects can be used in the laboratoryautomation system to detect the presence of and identify the targetobjects.

The camera unit 1814 is coupled to a lower end of a gripper 228 facingthe input area. The gripper 228 comprises a gripper body 228(a) andgripper fingers 228(b), which can grip a sample tube 1840. The gripper228 may also be attached to an X-Y gantry 1817 so that the gripper 228can move in an X, Y, or Z direction. A series of images is acquired bythe camera 1816 during the movement of the input gripper 228.

In this example, the target objects are one or more sample tubes beingprovided in one or more racks 1806 provided on the drawers 216 of theinput unit 202. The 2-D image can then be further processed by imageanalysis software to derive characteristic features of the target object(e.g., sample tubes and racks), such as tube cap indicators, rackmarkers, circular barcode labels, cap or rack color and shape, etc.

When the camera unit 1814 takes a series of images, the images can bestitched together by the analysis tool to generate an overview image.Within this overview image, single objects can be detected by imageanalysis performed by the analysis tool. For example, single objectssuch as markers on the holding racks or a cap or closure of a sampletube located in a holding rack can be detected using image analysis.

The embodiment in FIG. 5(c) has advantages. For example, using thisembodiment, a image can be taken of a sample tube rack with samples, andthe image can be analyzed, and the gripper can be instructed to selectthe appropriate sample tube from the sample tube rack and/or place atube in a vacant sample tube location in the rack. The gripper and itsrobotic arm and process information while it is moving, therebyresulting in a very efficient process.

FIG. 6 depicts an example overlay image of an original image and thehighlighted analyzed image of the sample tube identification in a samplerack based on a top-view image. Detected potential positions for asample tube are highlighted with circles 1902, while a detected sampletube is indicated by a cross 1904. Shape recognition software canrecognize outlines of potential locations for sample tubes byrecognition of particular shapes for the recesses that can receive thesample tubes. In some cases, the recesses in the rack may be colored toassist in the recognition of the empty recesses. Other rack locationswith sample tubes cover the empty recesses, and may therefore beconsidered to be filled with sample tubes. A map of circles and crossescan be formed as shown in FIG. 6, and this can be overlaid on a top planview image of the rack with the tubes. In some cases, the particularcharacteristics of the rack and the locations for sample tube placement(e.g., recesses) can be previously mapped and stored in a memory in thesystem. Thus, embodiments of the invention may determine the presenceand/or absence of a sample tube at a particular rack location in a rack.

The analysis tool according to an embodiment of the invention is alsocapable of deriving details such as cap color, cap shape, markers orlabels on the cap for a single sample tube in a holding rack, etc. Thederived details may then be used to optimize the subsequent processsteps for the laboratory automated system.

2. Sample Tube Marker

(a) Urgent Sample Indicator

The laboratory automation system can utilize a sample status indicatordevice, which can provide an easy way to mark a sample tube as anemergency or urgent tube requiring immediate analysis, without theapplication of additional material on the sample tube. Currently, sampletubes may be marked with self-adhering labels (e.g., colored labelsindicating urgency), “urgent” stickers, or just by using a handwrittennote indicating urgency on already existing labels. The urgent sampleindicator mechanism of the present technology can indicate urgency orstatus of the sample without the need to label or handwrite theindication.

The sample status indicator device includes a manually moveable elementof the sample tube cap, wherein the moveable element can be moved to atleast a first position and a second position. When the moveable elementis moved to a first position, a window may display a first status of thesample tube (e.g., normal or non-urgent). When the moveable element ismoved to a second position, the window may display a second status ofthe sample tube (e.g., a mark indicating an urgent status). Theindicator or marker can be read by operators as well as by an automatedsystem. The indicator or marker can be a particular color, characters,numbers, icons, etc.

For example, as soon as tubes with different priorities get collected ina multiple-tube rack, the conventional labels may get covered by therack itself of by neighbor tubes, thus making it difficult to recognizesuch labels or stickers as an emergency mark for automated processes. Inconventional situations, presorting must typically be performed. Theurgent sample indicator of the present technology can provide the visualmarker on the top of the tube so that the urgent tubes can be recognizedimmediately by users as well as by an automated process via imageprocessing. This allows the user to mix emergency samples together withlower priority samples in a rack or bag for transport. Undetectedemergency samples become unlikely, and additional presorting may not berequired.

The indicators in embodiments of the invention can be status indicators.Examples of particular tube statuses include, but are not limited to,the particular priority associated with a tube (e.g., urgent, noturgent, STAT, etc.), the particular processing desired for a tube (e.g.centrifuge, aliquot, etc.), etc.

In one embodiment, the markers are not limited to emergency orprioritization marking, and can alternatively allow for several visualpredefined marks, such as container content material, additives,reagents, etc., without the need for different parts. The moveableelement can be moved (e.g., a first direction or second direction) to acertain position so that the window displays a particular indicator.

In one embodiment, the positions to which the moveable element can bemoved may have a mechanical latch function or a limitation device toswitch between two or more positions. This prevents the moveable partfrom being accidentally moved to an incorrect position.

FIG. 7 shows a view of a sample tube 2002 comprising a sample tube body2004 and a cap 2000 on the sample tube body. A sample such as abiological sample can be present in the sample tube 2002. The sampletube body 2004 may comprise a transparent or translucent materialcomprising plastic or glass. The sample cap 2000 may also comprise amaterial such as plastic.

FIGS. 8(a)-8(b) depict one example of a cap 2000 having a movableelement that expose or not expose an urgent sample indicator.

In FIG. 8(a), the cap 2000 comprises a cylindrical cap body 2000(a) anda movable element 2000(b) at a top region of the cylindrical cap body2000(a). The movable element 2000(b) may rotate so that a window2000(b)-1 exposes a non-urgent indicator 2004. The non-urgent indicator2004 may be a color such as green to indicate that the sample is to beprocessed in a non-urgent manner. Handles 2000(b)-2 in the form ofprotrusions may be present in the movable element 2000(b) to allow ahuman, a gripper or other element to move the movable element 2000(b)change the status of the sample tub. While handles are described indetail, embodiments of the invention can include other types of handlingfeatures such as holes.

In FIG. 8(b), the movable element 2000(b) is rotated an emergency orurgent position to expose an urgent sample indicator 2005. The urgentsample indicator 2005 may be red to indicate that the sample tube is tobe processed as soon as possible.

While the indicators in FIGS. 8(a) and 8(b) are non-urgent 2004 andurgent 2005, respectively, it is understood that the sample tube cap2000 shown in FIGS. 8(a) and 8(b) could have other types of indicators.For example, the indicators may indicate that a sample is to beprocessed by a particular machine, by a particular process, in aparticular order, etc.

The cap 2000 and its indication of sample tube status can be viewed bythe camera units shown in FIGS. 5(a)-5(c) and can be identified andprocessed as described above.

(b) Centrifugation Indicator

The laboratory automation system can utilize a centrifugation statusindicator device, which can indicate whether a sample has beencentrifuged. Generally, the majority of sample tubes in a lab requirecentrifugation since only their serum is used for analysis. When asample tube sits for long period of time, there is sedimentation of thespecimen so that the specimen appears visually to have been spun.Additionally, it could become less apparent that a pre-spun sample wasactually already spun if the specimen were shaken (e.g., duringtransport). If sample tubes that have been sitting for a period of timeand pre-spun sample tubes are mixed, a user may not be able to discernwhich samples tubes were actually already spun. Furthermore, it may bedifficult for a user to visually determine the quality of thecentrifugation (e.g., whether or not the spin time and force (minutes*g)was sufficient or not).

The centrifugation status indicator device of the present technologyprovides a way to visualize the centrifugation status of a sample tube.The centrifugation status can be read by users or by a lab automationdevice independent from the actual appearance of the blood or otherspecimen in the sample tube. The centrifugation indicator prevents usererror which could result in incorrect test results. The centrifugationindicator provides a visual mark which changes its appearance duringcentrifugation according to the centrifugation time and force, but keepsits state under normal tube transport conditions.

The visual marker of the centrifugation indicator may be on the top ofthe sample tube so that it can be recognized immediately by users aswell as by an automated process via image processing. It allows pre-spunsamples to be mixed with un-spun samples in a rack and avoids the manualpresorting of samples prior to automation entry. In one embodiment, thecentrifuge indicator can be part of the sample tube cap for covering thesample tube.

Additionally, the centrifugation quality can be determined automaticallyand subsequent processes in the laboratory automation system can becontrolled according to the result. One embodiment of a centrifugationindicator is shown in FIG. 9(a). The centrifugation indicator depictedincludes a small container (which may be in the form of a cap housing)with a transparent top containing a colored gel 2302 (e.g. white) andparticles 2304 of a different (e.g., higher) density and with adifferent color (e.g., blue). In an unspun state 2104, the particles2304 and the colored get 2302 are distinct from each other. Using theexample of white gel 2302 and blue particles 2304, the initialappearance of the container may be light blue when the two componentsare initially mixed, or the appearance may be blue in case the particlesare on top of the gel 2302. During centrifugation, the blue particlesmove to the bottom of the container due to the higher density 2308, andthe top appearance changes to white due to the lack of particles 2310.The combination of the chosen materials provides the possibility to gaindifferent appearances according to the applied centrifugation force andtime. Additionally, more than one type of particles can be used to get afiner resolution of the applied spin time and force.

In one embodiment, the centrifugation indicator is a transparentcylinder that is pressed onto a pressure sensitive device (e.g.,pressure indicating film) which changes its appearance according to theapplied centrifugation force. FIG. 9(b) depicts an example of this typeof centrifugation indicator. The centrifugation indicator includes thepressure sensitive device 2312 (e.g., foil) in a transparent cylinder2314, which may comprise a transparent material such as a transparentgel. The transparent cylinder 2314 allows the pressure sensitive device2312 to be displayed. When the sample is not spun 2316, the pressuresensitive device 2312 may have a transparent appearance. Duringcentrifugation 2318, the pressure sensitive device 2312 on thecentrifugation indicator may have an appearance of one particular color.Once the sample tube has been spun 2320, the pressure sensitive device2312 on the centrifugation indicator may have another appearance ofanother particular color. One example of a pressure sensitive device2312 may be Prescale™ film by Fujifilm®.

FIG. 10(a) shows a side, cross-sectional view of a cap with a pressuresensitive device 2336 in the form of a foil. The cap is shown in anon-centrifuged state. As shown, the cap can include a body with acylindrical cap thread portion 2338 and a cylindrical cap top portion2334 separated by a perpendicular circular horizontal portion 2340. Apressure sensitive device 2336 is on the horizontal portion 2340. Aplurality of transparent posts 2332 may be on the pressure sensitivedevice 2336, and the top surfaces of the posts 2332 may be covered withan optically transparent cover 2330 (e.g., made of transparent plastic).

FIG. 10(b) shows a top plan view of the cap in FIG. 10(a). In FIGS.10(a) and 10(b), like reference numbers designated like elements. Asshown, the pressure sensitive device 2336 may be a first color when nopressure is applied to it.

The same cap is shown in FIGS. 11(a) and 11(b). However, this cap isshown after centrifugation. As shown, the posts 2332 applied downwardpressure on the pressure sensitive device 2336 causing a color change inthe pressure sensitive device 2336 at areas under the posts 2332. Whenviewed from the top in FIG. 11(b), a distinct pattern of three dots (ofa second color) is shown against a background of a different color(e.g., the first color). This pattern can be viewed by a camera lookingdown on the cap, and an analysis device coupled to the camera candetermine that the sample tube with the cap contains a centrifugedsample (as described above with respect to FIGS. 5(a)-5(c).

(c) Circular Barcode

The laboratory automation system can utilize a circular barcodeidentification device on top of a sample tube cap. A circular barcodecan provide for an easy and fast way to identify the sample tubes beforethey get handled by the input gripper for the first time.

The various participants and elements described herein with reference tothe figures may operate one or more computer apparatuses to facilitatethe functions described herein. Any of the elements in the abovedescription, including any servers, processors, or databases, may useany suitable number of subsystems to facilitate the functions describedherein, such as, e.g., functions for operating and/or controlling thefunctional units and modules of the laboratory automation system,transportation systems, the scheduler, the central controller, localcontrollers, etc.

Examples of such subsystems or components are shown in FIG. 12. Thesubsystems shown in FIG. 12 are interconnected via a system bus 4445.Additional subsystems such as a printer 4444, keyboard 4448, fixed disk4449 (or other memory comprising computer readable media), monitor 4446,which is coupled to display adapter 4482, and others are shown.Peripherals and input/output (I/O) devices, which couple to I/Ocontroller 4441 (which can be a processor or other suitable controller),can be connected to the computer system by any number of means known inthe art, such as serial port 4484. For example, serial port 4484 orexternal interface 4481 can be used to connect the computer apparatus toa wide area network such as the Internet, a mouse input device, or ascanner. The interconnection via system bus allows the central processor4443 to communicate with each subsystem and to control the execution ofinstructions from system memory 4442 or the fixed disk 4449, as well asthe exchange of information between subsystems. The system memory 4442and/or the fixed disk 4449 may embody a computer readable medium.

Embodiments of the technology are not limited to the above-describedembodiments. Specific details regarding some of the above-describedaspects are provided above. The specific details of the specific aspectsmay be combined in any suitable manner without departing from the spiritand scope of embodiments of the technology. For example, back endprocessing, data analysis, data collection, and other processes may allbe combined in some embodiments of the technology. However, otherembodiments of the technology may be directed to specific embodimentsrelating to each individual aspect, or specific combinations of theseindividual aspects.

It should be understood that the present technology as described abovecan be implemented in the form of control logic using computer software(stored in a tangible physical medium) in a modular or integratedmanner. Furthermore, the present technology may be implemented in theform and/or combination of any image processing. Based on the disclosureand teachings provided herein, a person of ordinary skill in the artwill know and appreciate other ways and/or methods to implement thepresent technology using hardware and a combination of hardware andsoftware.

Any of the software components or functions described in thisapplication, may be implemented as software code to be executed by aprocessor using any suitable computer language such as, for example,Java, C++ or Perl using, for example, conventional or object-orientedtechniques. The software code may be stored as a series of instructions,or commands on a computer readable medium, such as a random accessmemory (RAM), a read only memory (ROM), a magnetic medium such as ahard-drive or a floppy disk, or an optical medium such as a CD-ROM. Anysuch computer readable medium may reside on or within a singlecomputational apparatus, and may be present on or within differentcomputational apparatuses within a system or network.

The above description is illustrative and is not restrictive. Manyvariations of the technology will become apparent to those skilled inthe art upon review of the disclosure. The scope of the technologyshould, therefore, be determined not with reference to the abovedescription, but instead should be determined with reference to thepending claims along with their full scope or equivalents.

One or more features from any embodiment may be combined with one ormore features of any other embodiment without departing from the scopeof the technology.

A recitation of “a”, “an” or “the” is intended to mean “one or more”unless specifically indicated to the contrary.

All patents, patent applications, publications, and descriptionsmentioned above are herein incorporated by reference in their entiretyfor all purposes. None is admitted to be prior art.

What is claimed is:
 1. A sample container cap comprising: a sample capbody capable of covering an opening of a sample container; and acentrifugation status indicator device in the top of the sample capbody, wherein the centrifugation status indicator device comprises: afirst substance having a first density and a first color, wherein thefirst substance comprises a gel; and a second substance having a seconddensity and a second color, wherein the second substance comprises aplurality of particles, wherein the second density is higher than thefirst density and wherein the second color is different from the firstcolor, and wherein the centrifugation status indicator device displaysthe first substance when the sample container has been centrifuged. 2.The sample container cap of claim 1, wherein the first and secondsubstances are combined after centrifugation but are not combinedwithout centrifugation.
 3. The sample container cap of claim 1 whereinthe centrifugation status indicator device comprises a combination ofmaterials that change appearance according to applied centrifugationforce and time.
 4. The sample container cap of claim 1 wherein thesample cap body is transparent.
 5. The sample container cap of claim 4wherein the sample cap body is cylindrical.
 6. The sample container capof claim 4 wherein the sample cap body comprises a cap thread portion.7. The sample container cap of claim 1 wherein the sample cap bodyincludes a cylindrical cap thread portion and a cylindrical cap topportion, separated by a circular portion.
 8. A sample container capcomprising: a sample cap body capable of covering an opening of a samplecontainer; and a centrifugation status indicator device in the top ofthe sample cap body, wherein the centrifugation status indicator devicecomprises a pressure sensitive device extending in a first direction andtransparent cylindrical elements that contact the pressure sensitivedevice and that extend perpendicular to the first direction of thepressure sensitive device, wherein the transparent cylindrical elementsare configured to press onto the pressure sensitive device duringcentrifugation.
 9. The sample container cap of claim 8 wherein thepressure sensitive device comprises a foil configured to changeappearance in response to applied pressure.
 10. The sample container capof claim 9 wherein the foil is configured to change color in response toapplied pressure.
 11. The sample container cap of claim 8 wherein thepressure sensitive device comprises a pressure sensitive foil.
 12. Amethod comprising: attaching a sample container cap comprising a samplecap body, and a centrifugation status indicator device in the top of thesample cap body, to a sample container body containing a sample; andcentrifuging the sample in the sample container body, wherein thecentrifugation status indicator indicates a status of centrifugation,wherein the centrifugation status indicator device comprises: a firstsubstance having a first density and a first color, wherein the firstsubstance comprises a gel; and a second substance having a seconddensity and a second color, wherein the second substance comprises aplurality of particles, wherein the second density is higher than thefirst density and wherein the second color is different from the firstcolor, and wherein the centrifugation status indicator device displaysthe first substance when the sample container has been centrifuged. 13.The method of claim 12, wherein the centrifugation status indicatordevice comprises a combination of materials that change appearanceaccording to applied centrifugation force and time.
 14. The method ofclaim 12, wherein the sample cap body is transparent.
 15. The method ofclaim 12, wherein the sample cap body comprises a cap thread portion.16. A method comprising: attaching a sample container cap comprising asample cap body, and a centrifugation status indicator device in the topof the sample cap body, to a sample container body containing a sample;and centrifuging the sample in the sample container body, wherein thecentrifugation status indicator indicates a status of centrifugation,wherein the centrifugation status indicator device comprises a pressuresensitive device and transparent cylindrical elements that areperpendicular to the pressure sensitive device and contact the pressuresensitive device, wherein the transparent cylindrical elements pressonto the pressure sensitive device during centrifuging the sample. 17.The method of claim 16 wherein the pressure sensitive device comprises afoil configured to change appearance in response to applied pressure.